Biopsy Site Marker Deployment Device

ABSTRACT

A biopsy marker deployment device adapted to selectively deposit a marker in a target location, such as a biopsy site. In one embodiment, the device includes a deployment assembly comprising a cannula adapted to house at least one marker, an outlet aperture defined by a portion of the cannula, and an actuatable pushrod slidably disposed and movable within the cannula. The deployment assembly further comprises a selectively opening outlet door movable between an open position and a closed position. The outlet door is biased in the closed position and at least partially obstructs the aperture in the closed position to prevent a marker from reentering the cannula upon deployment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/305,141, filed Dec. 16, 2005, which is hereby incorporated byreference in its entirety as part of the present disclosure.

BACKGROUND

Biopsies and other techniques are commonly performed to remove a tissuesample from a selected site within the body. The sample may then beexamined and analyzed. Many biopsy devices make use of a hollow tubethat forms a working channel. The hollow tube is inserted into the sitefrom where the sample is to be taken. The hollow tube frequentlyincludes an aperture in communication with the working channel. Theaperture provides access between the working channel and the site to beanalyzed, which may be at some sub-cutaneous depth. This access allowssamples to be taken from the desired location.

In particular, the aperture is placed adjacent to the site from whichthe sample is to be taken. Thereafter, the tissue is drawn through theaperture and into the working channel, such as through the use of avacuum. A thin tube commonly referred to as a cutting cannula is thenpushed through the working channel. The cutting cannula is sized to fitclosely to the inner wall of the working channel. Thus, as the cuttingcannula is passed over the aperture, the cutting cannula cuts the tissueextending into the working channel. The tissue may then be removed andexamined.

It may be desirable to identify or “mark” the location of the biopsysite at some later point. For example, it may be desirable to have theability to return to the same site, such as to take further samplesand/or to provide further treatment to an affected area. In order toidentify the biopsy site, markers may be used. The markers frequentlyinclude a relatively small device or material that is readilyidentifiable. The markers are often introduced using a deployment devicein conjunction with the working channel of the biopsy device.

When introduced through the working channel of a biopsy device, currentmarker deployment devices do not effectively close off the aperture,resulting in gaps or dead space between the biopsy device and the markerdevice. This creates the potential for the marker to fall partially orcompletely back into the aperture of the biopsy device. As a result, themarker can be pulled out of the biopsy site when the biopsy device isremoved. This is known as “drag out.” Drag out can lead to the biopsysite not being identified, an incorrect area of tissue being identified,and treatment of the wrong site.

SUMMARY

Marker deployment devices are provided herein for depositing sitemarkers. The markers may be introduced to the biopsy sites throughapertures, such as an aperture formed in a working channel of a biopsydevice and/or an aperture formed in the deployment device. Thedeployment devices discussed herein are configured to close the apertureafter the marker has been deposited, such that the marker will not fallpartially or completely back into the deployment device. Thisconfiguration reduces the possibility that the marker will be draggedout when the deployment device is removed.

In one aspect, the invention is directed to a marker deployment deviceadapted to selectively deploy at least one marker stored therein to alocation external the device. The device comprises a cannula defining anaxially extending inner lumen adapted to receive at least one marker andan aperture in communication with the inner lumen; and a manuallyactuatable push rod slidably received and movable within the inner lumenof the cannula, wherein the pushrod, upon actuation, is adapted tocontact and urge at least one marker distally through the inner lumen ofthe cannula. The device further comprises a selectively opening outletdoor movable between an open position and a closed position, wherein thedoor (i) is configured to move to the open position upon contact with atleast one of the push rod and at least one marker, (ii) obstructs atleast a portion of the aperture when in the closed position and (iii) isbiased toward the closed position such that the door moves to the closedposition after a marker is deployed through the aperture to prevent themarker from re-entering the cannula upon deployment; and an inclinedsurface positioned within the inner lumen of the cannula adjacent to theaperture, wherein the inclined surface is adapted to guide at least onemarker from the inner lumen toward and through the aperture as themarker is urged by the push rod.

Details of one or more implementations of the invention are set forth inthe accompanying drawings and in the description below. Furtherfeatures, aspects, and advantages of the invention will become apparentfrom the description, the drawings, and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of the presentsystem and method and are a part of the specification. The illustratedembodiments are merely examples of the present system and method and donot limit the scope of the disclosure.

FIG. 1 illustrates a perspective view of a deployment device accordingto one exemplary embodiment.

FIG. 2 illustrates a cross-sectional view of a distal end of thedeployment device of FIG. 1 in more detail.

FIGS. 3A-3B are cross-sectional views that illustrate the deploymentaction of the deployment device of FIG. 2.

FIG. 4 is illustrates a cross-sectional view of a distal end of analternative embodiment of a deployment device according to one exemplaryembodiment.

FIG. 5 illustrates a cross-sectional view of the deployment device ofFIG. 4 at a first position relative to a working channel of a biopsydevice.

FIG. 6 is a cross-sectional view of the deployment device of FIG. 4illustrating the deployment action of the deployment device.

FIG. 7 illustrates a cross-sectional view of another embodiment of adeployment device in a first position according to one exemplaryembodiment.

FIG. 8 is a cross-sectional view of the deployment device of FIG. 7illustrating the deployment action of the deployment device depositing amarker.

FIG. 9 illustrates a cross-sectional view of another embodiment of adeployment device according to one exemplary embodiment.

FIG. 10 illustrates a cross-sectional view of the deployment device ofFIG. 9 in the process of deploying a marker.

FIG. 11A illustrates a cross-sectional view of the deployment device ofFIG. 9 in the process of deploying the marker.

FIG. 11B illustrates a cross-sectional view of the deployment device ofFIG. 9 in an intermediate stage of deploying the marker.

FIG. 11C illustrates a cross-sectional view of the deployment device ofFIG. 9 in a final stage of deploying the marker.

FIG. 12A illustrates a cross-sectional view of another embodiment of adeployment device according to one exemplary embodiment.

FIG. 12B illustrates a cross-sectional view of a portion of thedeployment device of FIG. 12A taken along lines 12B-12B.

FIG. 13 illustrates a cross-sectional view of the deployment device ofFIG. 12A in the process of deploying a marker.

FIG. 14 illustrates a cross-sectional view of the deployment device ofFIG. 12A after the marker has been deployed by the deployment device andpush rod has been retracted.

FIG. 15A illustrates a cross-sectional view of the deployment device ofFIG. 12A after the marker has been deployed and the push rod has secureda flexible member in place.

FIG. 15B illustrates a cross sectional view of the deployment device ofFIG. 15A taken along lines 15B-15B.

FIG. 16 illustrates a cross-sectional view of an alternative embodimentof a deployment device according to one exemplary embodiment.

Throughout the drawings, identical reference numbers designate similar,but not necessarily identical, elements.

DETAILED DESCRIPTION

An apparatus is provided herein for deployment of a marker. The markeris delivered by way of a lumen, such as the working channel of a biopsydevice or through the channel formed when performing a biopsy. Accordingto several exemplary embodiments discussed below, the marker deploymentdevice includes an elongated introduction device and a deploymentassembly. The deployment assembly deposits the marker through anaperture, and then at least substantially closes the aperture.Maintaining the aperture in a substantially closed position reduces thepossibility that the marker will fall back into deployment device.

In the following description, for purposes of explanation, numerousspecific details are set forth in order to provide a thoroughunderstanding of the present method and apparatus. It will be apparent,however, to one skilled in the art that the present method and apparatusmay be practiced without these specific details. Reference in thespecification to “one embodiment” or “an embodiment” means that aparticular feature, structure, or characteristic described in connectionwith the embodiment is included in at least one embodiment. Theappearance of the phrase “in one embodiment” in various places in thespecification are not necessarily all referring to the same embodiment.

FIG. 1 illustrates a marker deployment device (100) coupled to a workingchannel (110), such as the working channel of a biopsy device accordingto one exemplary embodiment. The working channel (110) has an aperture(120) defined therein. The deployment device (100) according to thepresent exemplary embodiment may include a hub (130) to which a cannula(131), (as best seen in FIG. 2) is connected. The cannula is selectivelyreceived within the working channel (110).

The deployment device (100) also includes a push rod (140), whichextends into the hub (130). In FIG. 1, a relatively large portion of thehub (130) is shown in contact with the proximal end of the workingchannel (110). This contact prevents further movement of the deploymentdevice (100) within the working channel (110). As the movement andlocation of the deployment device (100) is thus constrained, the pushrod (140) may then be advanced to deploy a marker.

The proximal end of the push rod (140) may include a plunger (141) thatis relatively large compared to the rest of the push rod (140), plunger(141) which may facilitate movement of the push rod (140) relative tothe working channel (110) as the deployment device (100) is actuated.Other components of the deployment device (100) will be discussed inisolation with reference to FIG. 2, while the operation of thedeployment device (100) will be discussed further with reference toFIGS. 3A-3B.

FIG. 2 illustrates a distal end (212) of the deployment device (100) inmore detail. As used herein, the distal end shall refer to a portionnearer the biopsy site while proximal shall refer to the end oppositethe distal end. As shown in FIG. 2, the marker deployment device (100)includes the cannula (131), the push rod (140), and an expandable member(200). The expandable member (200) forms a deployment assembly. Thedeployment assembly is configured to deposit a marker (210) whileminimizing space between the deployment device (200) and the device orarea used to introduce the deployment device. Further as seen in FIG. 2,the distal end (212) of the cannula (130) is open.

The distal end of the push rod (140) is coupled to the expandable member(200). Consequently, translation of the push rod (140) relative to thecannula (131) results in movement of the expandable member (200)relative to the cannula (131). The expandable member (200) is configuredto receive a marker (210). In particular, the expandable member (200)may be compressed by a predetermined amount to form a depression (214)appropriately sized such that the marker (210) may be received therein.FIG. 2 illustrates the push rod (140), expandable member (200), andmarker (210) retained within the cannula (131) at a first,pre-deployment position. In this first position, the expandable member(200) may be compressed within the cannula (131).

As introduced, according to one exemplary embodiment, the deploymentdevice (100) is delivered through the working channel (110) of a biopsydevice or other surgical device. In particular, the cannula (131) issized to slide relative to the working channel of the biopsy device.Thus, the distal end (212) of the deployment device (100) may beintroduced to the proximal end of the working channel (110). As thedeployment device is urged toward the distal end of the working channel(110), the push rod (140), the expandable member (200), and the marker(210) are maintained in their first position relative to the cannula(131).

The distal end of the deployment device (100) is urged toward the distalend of the working channel (110) a predetermined distance. In oneembodiment, the hub (130) comes into contact with the proximal end ofthe working channel (110) to serve as a stop member to define thepredetermined distance. As hub (130) comes into contact with theproximal end of the working channel (110), the cannula (131) isprevented from advancing further. With the location of the cannula (130)thus constrained, the push rod (140) may be actuated to deploy themarker (210).

The actuation of the push rod (140) is shown in FIGS. 3A-3B. Inparticular, FIG. 3A illustrates the cannula (130) located within theworking channel (110) of the biopsy device. According to the exemplaryembodiment shown in FIG. 3A, as the push rod (140) is urged through thedistal end of the cannula (130), the expandable member (200) contacts awall (216) at the distal end of the working channel (110) adjacentaperture (120). As the push rod (140) is further advanced, theexpandable member (200) acts against wall (216) and the internal surfaceof working channel (110) so to expand to fill the working channel (110).As the push rod (140) is urged further toward the distal end of theworking channel (110), the expandable member (200) expands through withthe aperture (120; best seen in FIG. 3A) in the working channel (110).

The expandable member (200) is expanded, thereby substantially fillingthe aperture (120). For example, according to one exemplary embodiment,the expandable member (200) is made of a resilient material that iscompressed while in the cannula (131) and the working channel (110).Such materials may include, without limitation, nitinol, an expandablemesh material, and/or shape memory material.

According to other exemplary embodiments, the material may besubstantially uncompressed or slightly compressed while in the cannula(131) and/or the working channel (110). When the push rod (140) isadvanced sufficiently the expandable member (200) comes into contactwith the wall (216) at the distal end of the working channel (110).Advancing the push rod (140) compresses the expandable member (200)about its length within the working channel (110). This compressioncauses the expandable member (200) to expand in a directionperpendicular to the compression. This expansion causes the expandablemember (200) to expand through the aperture (120).

As the expandable member (200) expands in a perpendicular direction, itcarries the marker (210) through the aperture (120) and into thesurrounding biopsy cavity. According to the exemplary embodiment shownin FIG. 3B, the expandable member (200) may be expanded a predeterminedamount to thereby deposit the marker (210) into the biopsy cavity.Thereafter, the expansion of the expandable member (200) may be reducedslightly to provide spacing between the expandable member (200) and thedeposited marker (210). The expandable member (200) remains sufficientlyexpanded to substantially fill the aperture (120), thereby sealing theaperture (120) and preventing the marker (210) from falling back intothe deployment device (100). Further, after deployment the workingchannel (110) may be rotated such that the opening (120) is rotated awayfrom the deployed marker (210), thereby further preventing that themarker (210) does not fall back into the working channel (110).

The deployment device (100) may then be withdrawn, such as bywithdrawing the working channel (110) with the expandable member (200)expanded to maintain a seal about the aperture (120). Thus, as thedeployment device is removed, the aperture remains substantially sealed,thereby minimizing or reducing the possibility that the marker (210)will fall partially or completely into the working channel (110) andthus be dragged out. While the marker deployment device (100) has beendescribed with reference to a working channel (110), those of skill inthe art will appreciate that other configurations are possible. Forexample, according to one exemplary embodiment, the deployment device(100) may be introduced to the biopsy site by way of the tissue trackcreated by a biopsy device in creating the biopsy site. Otherconfigurations are also possible, as will now be discussed in moredetail.

FIGS. 4, 5, and 6 illustrate a deployment device (400) that includes acannula (410), a push rod (420), a protruding member (430), a receivingmember (440), and a strip of flexible material (450). FIG. 4 illustratesthe deployment device (400) in isolation. FIG. 5 illustrates thedeployment device (400) at a first, pre-deployment position relative toa working channel (110). FIG. 6 illustrates the deployment device (400)deploying a marker (210).

As shown in FIG. 4, a seat (460) is defined in the push rod (420). Astrip of flexible material, hereinafter referred to as a flexible strip(450), has a first position that is coupled to the receiving member(440). The receiving member is detachably coupled to a distal end ofpush rod (420). The flexible strip (450) extends from the receivingmember (440), and along the surface of a seat (460). A second portion offlexible strip (450) is connected to a portion of push rod (420),adjacent seat (460), opposite receiving member (440). Thus, while in thefirst position, the marker (210), which is positioned in the seat (460),rests on the flexible strip (450) while the marker (210) is receivedwithin the seat (460).

Further, as shown in FIG. 4, the distal end of the cannula (410) issubstantially closed. Additionally, a cannula aperture (470) is definednear the distal end of the cannula (410). According to the presentexemplary embodiment, the protruding member (430) is disposed at or nearthe closed distal end of the cannula (410). The protruding member (430)is configured to be matingly coupled to the receiving member (440).

In particular, as shown in FIG. 5, the cannula (410) may be advancedrelative to the working channel (110) until the distal end of thecannula (410) comes into contact with the distal end of the workingchannel (110). At this position, the cannula aperture (470) is alignedrelative to the aperture (120) defined in the working channel (110).Thereafter, the push rod (420) may be advanced until the receivingmember (440) comes into contact and engages with the protruding member(430). This contact couples the receiving member (440) to the protrudingmember (430). As the receiving member (440) is coupled to the protrudingmember (430), the seat (460) is aligned relative to the both the cannulaaperture (470) and the aperture (120) defined in the working channel(110).

Thereafter, the push rod (420) may deploy the marker (210) whileminimizing the possibility that the marker (210) will fall completely orpartially back into the seat (460), the cannula aperture (470), and/orthe aperture (120) defined in the working channel (110). Such aconfiguration is shown in FIG. 6. In particular, as previouslydiscussed, the protruding member (430) is coupled to the receivingmember (440). As the push rod (420) is retracted, the protruding member(430) retains the receiving member (440) in contact therewith.

As the push rod (420) is retracted, the first portion of flexible strip(450) is retained in contact with the receiving member (440) and thesecond portion of flexible strip (450) is retained to a portion of thepush rod (420). Consequently, as the distal end of the push rod (420) isretracted while the flexible strip (450) remains stationary, a centerportion of flexible strip (450) that is positioned over seat (460)extends upwardly, carrying marker (210) through aperture (470).

As the center portion of flexible strip (450) is driven upward and outof the seat (460), the marker (210) is also upwardly displaced. Asintroduced, when the distal end of the cannula (410) is in contact withthe distal end of the working channel (110), the cannula aperture (470)and the aperture (120) in the working channel (110) are aligned. As themarker (210) is driven upward, it is urged through the cannula aperture(470), through the aperture (120) in the working channel (110), and thendeposited into the biopsy site.

As the marker (210) is deposited into the biopsy site, the flexiblestrip (450) closes the cannula aperture (470) and minimizes the spacebetween the aperture (120) in the working channel (110) and the cannula(410). Thus, as the deployment device (400) and the working channel(110) are removed, the flexible strip (450) minimizes the possibilitythat the marker (210) will fall partially or completely back into theworking channel (110) or cannula (410). While a working channel of abiopsy device has been described in introducing the deployment device toa biopsy site, those of skill in the art will appreciate that thedeployment device (400) may be introduced in other ways, such as by thetract formed by the biopsy device when performing the biopsy.

FIGS. 7 and 8 illustrate a deployment device (700) that includes acannula (710), a push rod (720), a platform (730), and at least onebiasing member, such as springs (740). In particular, FIG. 7 illustratesthe deployment device (700) in isolation while in a first,pre-deployment position. As seen in FIG. 7, the cannula (710) has acannula aperture (750) defined therein. While in the first position, thepush rod (720) is positioned behind the cannula aperture (750). In thisposition, the marker (210) is carried by the platform (730). In thisposition, the springs (740) associated with the platform (730) areretained in a compressed position within the cannula (710) with ends(755, 760) of platform (730) being functionally retained by shoulders(770, 780).

The push rod (720) is advanced to actuate the deployment device, asshown in FIG. 8. As shown in FIG. 8, the deployment device (700) may beintroduced to a biopsy site with a working channel (110). Morespecifically, according to one exemplary embodiment, the cannula (710)is advanced relative to the working channel (110) until the distal endof the cannula (710) comes into contact with the distal end of theworking channel (110). As the cannula (710) is thus advanced, the pushrod (720) is maintained in the first position described above. Further,as the cannula (710) comes into contact with the distal end of theworking channel (110), the cannula aperture (750) is aligned relative tothe aperture (120) defined in the working channel (110).

Thereafter, the push rod (720) may be advanced relative to the cannula(710). For example, the push rod (720) may be advanced until a distalend (790) of the push rod (720) contacts an inner wall (795) of cannula(710). In one embodiment, the contact between the inner wall (795) andthe distal end (790) of push rod (720) causes the shoulders (770, 780)to flex, thereby releasing the platform (730).

In another embodiment, one of the shoulders (780) is constructed of acompressible material. As the push rod (720) is advanced relative to thecannula (710), the compressible shoulder (780) contacts an abutment thatextends downwardly into the cannula (710) adjacent the cannula aperture(750) such that the compressible shoulder (780) compresses, therebyreleasing the platform (730).

Once the platform (730) is released, the biasing elements (740) push theplatform (730) and the marker (210) carried therein upwardly, therebydeploying the marker (210) into the biopsy cavity. More specifically, aspreviously introduced, while in the body of the cannula (710), theplatform (730) is retained in a compressed position. As the platform(730) is moved into communication with the cannula aperture (750), thebiasing elements (740) release the platform (730) from the cannula(710).

According to one exemplary embodiment, the platform (730) and thecannula aperture (750) are slightly larger than the aperture (120)defined in the working channel (110). Thus, as the platform (730) isreleased, it is urged outward until it comes into contact with theworking channel (110). Thus, the platform (730) obstructs the aperture(120). As the platform (730) is thus urged outwardly, the marker (210)is pushed through the aperture (120) and is thus deposited in the biopsysite.

The deployment device (700) may then be removed. The deployment device(700) and working channel (110) may be removed while the platform (730)remains in position to obstruct the aperture (120). Thus, the deploymentdevice (700) is configured to deposit the marker (210) while minimizingthe possibility that the marker (210) will fall partially or completelyinto the working channel (110) and/or the deployment device (700).Accordingly, the deployment device (700) minimizes the possibility ofdrag out. While a working channel has been described for introducing thedeployment device to the biopsy site, those of skill in the art willappreciate that the deployment device (700) may be introduced by anysuitable means, such as through the tract cut by a biopsy device increating the biopsy site.

FIGS. 9, 10, and 11 illustrate a deployment device (900) that includes aselectively opening outlet (905) according to one exemplary embodiment.An exemplary embodiment will be discussed that includes a cannula (910)with the selectively opening outlet (905) coupled thereto. A push rod(930) is received within the cannula (910). As will be discussed in moredetail below, the selectively opening outlet (905) allows the marker(210) to be selectively deployed in a biopsy site while minimizing thepossibility that the marker will be dragged out as the deployment device(900) is removed.

FIG. 9 illustrates the deployment device (900) in a first,pre-deployment position within a working channel (110). As shown in FIG.9, the push rod (930) is sized to translate within the cannula (910). Aramp (940) or other inclined surface is formed in the distal end of theinner cannula (910). In the preliminary position, the marker (210) islocated in a marker staging cavity (920) defined in the space betweenthe distal end of the cannula (910) and the distal end of the push rod(930). In the first position, the selectively opening outlet (905), andthe aperture (120) defined in the working channel (110) are aligned.

The push rod (930) is actuated to selectively open the selectivelyopening outlet (905) and deposit the marker (210) in a biopsy site. Inparticular, FIG. 10 illustrates the push rod (930) being advanced towardthe ramp (940). The push rod (930) may be flexible or rigid.Alternatively, the push rod (930) may be formed with a flexiblematerial, but also includes a stiffening sleeve therein. Further, thepush rod may be formed of any suitable material. Suitable materialsinclude, without limitation, plastic and metallic materials. As the pushrod (930) is thus advanced, the distal end of the push rod (930)contacts the marker (210) thereby urging the marker (210) toward theramp (940). As the marker (210) engages the ramp (940), an end of themarker (210) is urged into contact with the selectively opening outlet(905).

According to one exemplary embodiment, the selectively opening outlet(905) is biased to remain in a closed position. For example, the cannula(910) and selectively opening outlet (905) may be formed of a resilientmaterial, such as a plastic material. Accordingly, the selectivelyopening outlet (905) may be biased to remain in a closed position. Afterthe marker (210) is moved into contact with the selectively openingoutlet (905), continued advancement of the push rod (930) drives themarker (210) further up the ramp (940). In one embodiment, the push rod(930), which may have at least a distal end portion that has apredetermined degree of flexibility is advanced such that the distal endof the push rod is advanced through the selectively opening outlet (905)to insure that the marker (210) fully exits the deployment device (900).

As illustrated in FIG. 11A, the pushrod (930) is advanced and bends atthe interface of ramp (940) in a flexion region (950). The marker (210)moves further up the ramp (940) and the marker (210) deflects theselectively opening outlet (905) outwardly. Thus, the bias whichmaintains the selectively opening outlet (905) closed is overcome andthe selectively opening outlet (905) is opened. As illustrated in FIG.11B, the push rod (930) is further advanced until the marker (210)continues through the selectively opening outlet (905) through theaperture (120) defined in the working channel (110), and into the biopsysite.

FIG. 11C illustrates the deployment device in a final stage of deployingthe marker. As introduced, the selectively opening outlet (905) isbiased to stay in a closed position. Thus, as the marker (210) clearsthe selectively opening outlet (905), the selectively opening outlet(905) returns to a closed position relative to the cannula (910).Accordingly, after the marker (210) has been deposited, the selectivelyopening outlet (905) closes, thereby closing off the cannula (910) whileminimizing any space between the cannula (910) and the working channel(110). Once the marker (210) has been deposited, the deployment device(900) and working channel (110) may be removed without the marker (210)being dragged out. Further, selectively opening outlet (905) closesbehind marker (210) and prevents marker (210) from following push rod(930) back within working channel (110). As can be seen with FIGS.9-11C, the cross section of push rod (930) is smaller than marker (210).The difference in size provides for the selectively opening outlet (905)to “wipe off” marker (210) from the distal end of push rod (930). This“wiping off” action occurs because the bias of selectively openingoutlet (905) follows the smaller cross section of push rod (930) andallows the selectively opening outlet (905) to begin closing behindmarker (210).

While a working channel has been described for introducing thedeployment device to the biopsy site, those of skill in the art willappreciate that the deployment device (900) may be introduced by anysuitable means, such as through the tract cut by a biopsy device whencreating the biopsy site.

FIGS. 12-15 illustrate a deployment device (1200) that includes aflexible strip (1210) having a first end secured to an internal wall(1212) of a distal end of a cannula (1220). FIG. 12A illustrates thecomponents of the deployment device (1200) in a first, pre-deploymentposition. As shown in FIG. 12A, the deployment device (1200) alsoincludes a push rod (1230). In the first position, the push rod (1230)has a distal end (1232) that extends over a portion of a proximal end(1234) of the flexible strip (1210) thereby depressing a portion of theflexible strip (1210).

The cannula (1220), according to the present exemplary embodiment, has acannula aperture (1240) defined therein. The cannula aperture (1240) isadjacent the distal end of the cannula (1220). The distal end offlexible strip (1210) is secured to the internal wall (1212) at thedistal end of the cannula (1220) and aligned with the proximal anddistal edge of aperture (1240). In the first position, the flexiblestrip (1210) extends away from the distal end of the cannula (1220) pastthe cannula aperture (1240) and beyond the distal end (1232) of the pushrod (1230).

The flexible strip (1210) is preliminarily and selectively retained inthis position by the push rod (1230). More specifically, FIG. 12Billustrates a cross sectional view taken along section 12B-12B As shownin FIG. 12B, in the first position, the proximal end of the flexiblestrip (1210) is retained between the distal end (1232) of the push rod(1230) and an interior wall of the cannula (1220). With the flexiblestrip (1210) thus retained, the flexible strip (1210) defines aretaining cavity (1250) that extends into a flexible ramp. In thisposition, the marker (210) rests on the flexible strip (1210) within theretaining cavity (1250) near the distal end (1232) of the push rod(1230).

The deployment device (1200), according to the present exemplaryembodiment, is actuated by advancing the push rod (1230). As the pushrod (1230) is advanced, the distal end (1232) of the push rod (1230)comes into contact with the marker (210). As a result, when the push rod(1230) is advanced, the marker (210) is also advanced.

In particular, as shown in FIG. 13, as the marker (210) is advanced, itis driven along the flexible strip (1210), thereby reducing the size ofthe retaining cavity (1250). More specifically, the marker (210) isadvanced along the flexible strip (1210) and up the flexible ramp suchthat the push rod (1230) captures an increased length of the flexiblestrip (1210). The push rod (1230) is advanced until the marker (210) isdriven through the cannula aperture (1240) such that the marker (210) isdeployed in the biopsy site.

Once the marker (210) is deployed, the push rod (1230) may be withdrawnuntil the push rod (1230) is behind the flexible strip (1210) and nolonger retaining the proximal end (1234) of the flexible strip (1210).As previously discussed, while in the preliminary position and while themarker (210) is being deployed, the push rod (1230) depresses theflexible strip (1210). According to such an exemplary embodiment, theflexible strip (1210) is formed of a resilient material that isconfigured to spring back to a shape when not depressed by the push rod(1230). Thus, the push rod (1230) may temporarily retain the flexiblestrip (1210) until it is no longer in contact with the flexible strip(1210).

Thereafter, the flexible strip (1210) will automatically return to itsun-depressed state when the push rod is removed, as shown in FIG. 14.According to the present exemplary embodiment, as the flexible strip(1210) returns to its un-depressed state, it obstructs the cannulaaperture (1240). With the cannula aperture (1240) thus obstructed, theflexible strip (1210) minimizes the possibility that the marker (210)may fall partially or completely back into the deployment device (1200).

As seen in FIGS. 15A and 15B, the push rod (1230) may be advancedslightly after the flexible strip (1210) is released from its depressedstate to thereby securely close the cannula aperture (1240). As seen inFIG. 15A, as the push rod (1230) is again advanced, the push rod (1230)secures the flexible strip (1210) to the cannula (1220). Morespecifically, the push rod (1230) maintains the proximal end (1234) ofthe flexible strip (1210) on the side of the cannula aperture (1240).Thus, as seen in FIG. 15B, the flexible strip (1210) is located betweenthe push rod (1230) and the cannula (1220) on the side of the cannulaaperture (1240), thereby securely closing the cannula aperture (1240).The deployment device (1200) may thus be withdrawn while minimizing thepossibility that the marker (210) will fall partially or completely intothe deployment device (1200), and thus be dragged out.

FIG. 16 illustrates a deployment device (1600) according to oneexemplary embodiment. As shown in FIG. 16, the deployment device (1600)includes an arm (1610) that is pivotally connected to an internalsurface of a cannula (1620). One or more biasing elements (1650), suchas a spring, are secured to the arm (1610) to move the arm (1610) from apre-deployment position to a deployment position (shown in phantom). Amarker (210) is positioned on a surface of the arm (1610). The cannula(1620) further has a cannula aperture defined therein (1630), where theaperture (1630) is positioned over the arm (1610). The deployment device(1600) may be introduced through the working channel (110) of a biopsydevice.

The deployment device (1600) further includes a selectively retractablecover (1640). When the deployment device (1600) is in a first,pre-deployment position, the cover (1640) is positioned over the arm(1610) that is carrying the marker (210). A slot (1642) is formed on abottom portion of cover (1640) to permit cover (1640) to pass over thearm (1610). When the sleeve extends over the arm (1610), arm (1610) isheld down such that the marker (210) is retained within the deploymentdevice (1600). However, the cover (1640) may be selectively retracted,such that the biasing element (1650) pivots the arm (1610) upwardly,protruding the marker (210) out of the aperture (1630). Once deployed,the cover (1640) may be slid back over the arm (1610) and extends pastthe aperture (1630) to the distal end of cannula (1620). Thus, the cover(1640) dislodges the marker (210) from the arm (1610) and obstructs theaperture (1630) thereby preventing the marker (210) from re-entering thedeployment device (1600).

In another embodiment, deployment device (1600) may be used with acannula within a cannula system (e.g., a cutting instrument). FIG. 16further illustrates the cannula with a cannula system wherein the cover(1640) is embodied as the inner cutting instrument element. The distalend of cover (1640) may then be used to hold down the arm (1610).

The preceding description has been presented only to illustrate anddescribe exemplary embodiments. It is not intended to be exhaustive orto limit the disclosure to any precise form disclosed. Manymodifications and variations are possible in light of the aboveteaching. It is intended that the scope of the disclosure be defined bythe following claims.

1. A marker deployment device adapted to selectively deploy at least onemarker stored therein to a location external the device, comprising: acannula defining an axially extending inner lumen adapted to receive atleast one marker and an aperture in communication with the inner lumen;a manually actuatable push rod slidably received and movable within theinner lumen of the cannula, wherein the pushrod, upon actuation, isadapted to contact and urge at least one marker distally through theinner lumen of the cannula; a selectively opening outlet door movablebetween an open position and a closed position, wherein the door (i) isconfigured to move to the open position upon contact with at least oneof the push rod and at least one marker, (ii) obstructs at least aportion of the aperture when in the closed position and (iii) is biasedtoward the closed position such that the door moves to the closedposition after a marker is deployed through the aperture to prevent themarker from re-entering the cannula upon deployment; and an inclinedsurface positioned within the inner lumen of the cannula adjacent to theaperture, wherein the inclined surface is adapted to guide at least onemarker from the inner lumen toward and through the aperture as themarker is urged by the push rod.
 2. The device of claim 1, wherein theoutlet door is hinged to an outer wall of the cannula and extends atleast partially over the aperture when in the closed position.
 3. Thedevice of claim 1, wherein the outlet door is defined by a portion of anouter wall of the cannula adjacent the aperture and extends at leastpartially over the aperture when in the closed position.
 4. The deviceof claim 3, wherein the interface between the outlet door and the outerwall of the cannula defines a flexible hinge.
 5. The device of claim 4,wherein the cannula further includes an internal wall positionedadjacent the aperture.
 6. The device of claim 5, wherein the internalwall is inclined so as to form the inclined surface within the innerlumen of the cannula.
 7. The device of claim 1, wherein at least adistal end of the push rod is flexible.
 8. The device of claim 1,wherein the push rod is sized so as to partially extend out of saidaperture when fully actuated.
 9. The device of claim 1, wherein saidpush rod is substantially rigid but includes a flexible tip.
 10. Thedevice of claim 3, wherein the outlet door extends away from theinternal lumen of the cannula when in the open position.
 11. The deviceof claim 1, further comprising at least one marker stored within theinner lumen of the cannula.
 12. The device of claim 11, wherein thecross section of the pushrod is less than the cross section of the atleast one marker.